The percentage of successful treatment episodes, defined as having achieved control of the bleeding episode within One Loading Dose and 8 or fewer Treatment Doses, with a dose limit of 1000 U/kg in 24 hours

Evaluate the efficacy, safety and pharmacoeconomic of long-term secondary prophylaxis with Kogenate Bayer in comparison to on-demand treatment with Kogenate Bayer in terms of joint bleeding episodes per year

Number of participants with reduction of annualized bleeding rate (ABR) for spontaneous (not related to trauma) bleeding episodes during prophylaxis relative to the participants' own historical ABR during on-demand treatment

Number of participants with zero bleeds during prophylactic treatment with recombinant von Willebrand factor (rVWF)

(and 25 more...)

22

All

18 Years and older (Adult, Older Adult)

NCT02973087

0713012016-001478-14

December 22, 2017

May 20, 2019

May 20, 2019

November 25, 2016

March 6, 2018

University of Florida College of MedicineGainesville, Florida, United States

Bleeding and Clotting Disorders InstitutePeoria, Illinois, United States

Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)